Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 10/21/2023 |
Event Type
Injury
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Event Description
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An adhesive issue was reported with the abbott diabetes care (adc) sensor.The sensor prematurely detached after fourteen days or less of wear and the customer was unable to obtain readings or monitor glucose levels.As a result, customer experienced a loss of consciousness, seizure, and was unable to self-treat, requiring going to the hospital.At the hospital, a healthcare professional (hcp) provided third-party treatment of intravenous "glucose infusion" for a diagnosis of hypoglycemia and remained in the hospital for a week.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date of event is unknown.The date entered in section b3 is the date "two months ago" prior to when abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An adhesive issue was reported with the abbott diabetes care (adc) sensor.The sensor prematurely detached after fourteen days or less of wear and the customer was unable to obtain readings or monitor glucose levels.As a result, customer experienced a loss of consciousness, seizure, and was unable to self-treat, requiring going to the hospital.At the hospital, a healthcare professional (hcp) provided third-party treatment of intravenous "glucose infusion" for a diagnosis of hypoglycemia and remained in the hospital for a week.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor kit was reviewed and the dhrs showed the libre sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed, and a follow-up report submitted.This serves as a correction report.Section h4(device mfg date) and section h10 (additional mfg narrative) were incorrectly updated in the previous report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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